A Phase I, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies

Study Identifier:
FS222-19101
CT.gov Identifier:
NCT04740424
EudraCT Identifier:
2020-003021-28
EU Trial (CTIS) Number:
2024-514010-12-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate safety, pharmacology and anti-tumor activity of FS222 in cancer

To assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours

To evaluate the safety, tolerability, and early signs of efficacy of FS222 in adult patients diagnosed with advanced malignancies

To evaluate FS222 in an open-label, multi-center study in patients with advanced treatment-refractory solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Metastatic Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm
    • Read More
  • Drug: Subjects will receive FS222. There will be PK/PD expansion cohorts and tumor specific expansion cohorts.
  • Drug: Part A consists of an accelerated dose titration (ADT) involving single-subject cohorts followed by a classical 3+3 design and dose expansion cohorts in selected tumor types to further characterize safety, PK/PD and clinical efficacy. Part B consists of tumor-specific efficacy expansion cohorts with Bayesian adaptive statistics.
  • Drug: EIOC 2022:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Age > or =18 years.
    • Participants with histologically or cytologically confirmed, locally advanced, unresectable or metastatic solid tumours for whom standard therapy has proven to be ineffective, intolerable or is considered inappropriate. This criterion does not apply to the PK/PD expansion cohort, where tumour-specific criteria will apply instead.
    • No more than 1 line of prior therapy with ICB treatment. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
    • Participants who have received prior ICB, or any concurrent chemotherapy, radiotherapy, investigational, biologic or hormonal therapy for cancer treatment may be eligible for enrolment following a washout period.
    • Participants who have received prior anti-PD-L1 therapy are eligible if PD-L1 therapy was discontinued =6 months prior to entry into the study.
    • Participants who have failed a prior ICB regimen should document it.
    • Measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
    • Eastern Cooperative Oncology Group Performance Status < or = 1.
    • The participant agrees to undergo a mandatory pre-treatment and on-treatment biopsy of the tumour. Certain exceptions apply.
    • Highly effective contraception.
    • Willing and able to provide written informed consent.
    Exclusion criteria
    • Participants with clinically relevant COVID-19 disease risk will be excluded from enrolment during the COVID-19 pandemic.
    • Concurrent enrolment in another clinical study with the exception of non-interventional/observational studies or the follow-up period of an interventional study.
    • Prior treatment with CD137 agonist mAb or other experimental agonists.
    • For participants who have received prior ICB, participants must not have received more than 1 line of prior treatment with ICB(s). Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
    • Participants with active autoimmune disease.
    • Receipt of any live virus vaccine within 30 days prior to the first dose of study drug.
    • Receipt of a live attenuated vaccine within 30 days prior to the first dose of study drug.
    • History of uncontrolled intercurrent illness.
    • Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
    • Judgment by the investigator that the participant is unsuitable to participate in the study, and the participant is unlikely to comply with study procedures, restrictions and requirements.
    • Significant laboratory abnormalities.
    • Known infections.
    • Uncontrolled CNS metastases, primary CNS tumours with CNS metastases as only measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
    • Prior history of any Grade > or = 3 irAE that has not improved to Grade =1, except for endocrine deficiencies that are managed by HRT; significant treatment-related cytokine release syndrome; systemic inflammatory response syndrome.
    • Current use of immunosuppressive agents, prior organ transplantation requiring immunosuppression, hypersensitivity or intolerance to mAb or their excipients, or persisting toxicity related to prior therapy of Grade >1 NCI CTCAE Version 5.0 .

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Metastatic Cancer